Specialist, Quality & Compliance - Technology Transfer

Jubilant Pharma, LLC; India; A distancia; INR 11.439.000 - 15.253.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive compensation

401K matching

Home-based role with travel

Descripción de la vacante

Jubilant Radiopharmacies seeks a Specialist in Quality & Compliance for Technology Transfer, primarily home-based with 40-60% travel to PET manufacturing sites. This two-year contract role leads Quality in tech transfer, ensuring cGMP compliance across the network and readiness for inspections.

You will review plans, change controls, validation docs, CAPAs, and perform risk assessments while partnering with Operations and Validation to enable timely launches and site startups.

Formación

• Bachelor's degree in science/engineering; Master's preferred.
• At least 5 years pharmaceutical Quality experience.
• Minimum 3 years supporting sterile manufacturing operations.
• Experience with technology transfer, commercial manufacturing and change management.
• Experience reviewing validation documentation including IQ/OQ/PQ, CSV, process validation and method qualification.
• Experience with FDA inspections, investigations, deviations, CAPAs, and Quality Risk Management.
• Strong knowledge of FDA Part 212, Part 211, Part 11, ICH Q9, USP <825>, GAMP 5, and cGMP requirements.
• Radiopharmaceutical or PET manufacturing experience strongly preferred.

Responsabilidades

• Act as Quality representative for technology transfer projects across the PET manufacturing network.
• Review and approve Technology Transfer Plans, Change Controls, risk assessments, validation documentation, and GMP records.
• Partner with Operations, Validation, and project teams to support new product launches, site startups, customer transfers, and commercial implementation activities.
• Perform quality gap assessments between transferring and receiving sites.
• Facilitate Quality Risk Assessments (ICH Q9) and ensure appropriate mitigation plans are executed.
• Support manufacturing readiness activities, including training, qualification, validation, and documentation review.
• Review deviations, investigations, root cause analyses, and CAPAs related to technology transfer activities.
• Support customer audits and FDA inspections.
• Drive continuous improvement initiatives that strengthen quality systems and technology transfer execution.

Conocimientos

Pharma quality experience

Sterile manufacturing knowledge

Technology transfer

QA oversight

FDA inspections experience

Quality Risk Management (ICH Q9)

Cross-functional collaboration

Educación

Bachelor's degree in Science/Engineering

Master's degree preferred

Herramientas

IQ/OQ/PQ

CSV

GAMP 5

Descripción del empleo

Specialist, Quality & Compliance - Technology Transfer

Location: Home-based with travel to sites (approximately 40-60%)

Two (2) year contract

Join Jubilant Radiopharmacies

At Jubilant Radiopharmacies, we help bring critical diagnostic imaging products to patients across North America. As our network continues to grow, we're looking for a quality professional with radiopharmaceutical or sterile manufacturing technology transfer experience to help lead the successful introduction of products, processes, and technologies across our PET manufacturing sites.

The Opportunity

This is a highly visible role for someone who enjoys working at the intersection of Quality, Operations, Validation, and Technology Transfer. You'll serve as the Quality lead for technology transfer projects, ensuring new products and processes are implemented efficiently while maintaining compliance with cGMP requirements and inspection readiness. If you've supported radiopharmaceutical, PET, or sterile manufacturing transfers and enjoy building quality into complex projects, we'd like to hear from you.

What You'll Do

• Act as the Quality representative for technology transfer projects across the PET manufacturing network.
• Review and approve Technology Transfer Plans, Change Controls, risk assessments, validation documentation, and GMP records.
• Partner with Operations, Validation, and project teams to support new product launches, site startups, customer transfers, and commercial implementation activities.
• Perform quality gap assessments between transferring and receiving sites.
• Facilitate Quality Risk Assessments (ICH Q9) and ensure appropriate mitigation plans are executed.
• Support manufacturing readiness activities, including training, qualification, validation, and documentation review.
• Review deviations, investigations, root cause analyses, and CAPAs related to technology transfer activities.
• Support customer audits and FDA inspections.
• Drive continuous improvement initiatives that strengthen quality systems and technology transfer execution.

What We’re Looking For

• Bachelor's Degree in Science, Engineering, or a related field; Master's Degree preferred.
• Minimum 5 years of pharmaceutical Quality experience.
• Minimum 3 years supporting sterile manufacturing operations.
• Experience supporting technology transfer, commercial manufacturing, and change management activities.
• Experience reviewing validation documentation, including IQ/OQ/PQ, CSV, process validation, and method qualification activities.
• Experience with FDA inspections, investigations, deviations, CAPAs, and Quality Risk Management.
• Strong knowledge of FDA Part 212, FDA Part 211, Part 11, ICH Q9, USP <825>, GAMP 5, and cGMP requirements.
• Radiopharmaceutical or PET manufacturing experience strongly preferred.
• Ability and willingness to travel up to 40-60%.

Why Join Jubilant?

• Play a key role in expanding innovative radiopharmaceutical manufacturing capabilities.
• Work with experienced quality and operational leaders across a growing network.
• Influence major technology transfer and commercial launch initiatives.
• Enjoy the flexibility of a home-based role with meaningful project ownership.

Compensation & Benefits

We offer competitive compensation, generous vacation, and 401K matching.

Equal Opportunity Employer

Jubilant Radiopharmacies is committed to fostering an inclusive workplace where everyone is respected, valued, and has the opportunity to succeed. We welcome applicants from all backgrounds and provide reasonable accommodations throughout the recruitment process as required by applicable law.